Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage

Official title

Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage: A Multicenter, Prospective, Cluster-Randomized, Open-Label, Blinded-Endpoint Clinical Trial

Overview

MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.

Detailed description

Intensive BP-lowering initiated within 3 hours of intracerebral haemorrhage onset may reduce the risk of hematoma expansion and improve functional outcome.

This trial is designed to evaluate whether, compared with Emergency Medical Services (EMS), the Mobile Stroke Unit (MSU) can improve outcomes in patients with spontaneous intracerebral hemorrhage by reducing onset-to-treatment time.

This is a multicenter, prospective, open-label, blinded endpoint, alternating week, cluster-controlled trial.

Patients with suspected stroke who present within 3 hours of symptom onset and have a systolic blood pressure ≥150 mmHg will be enrolled in the trial. The primary analysis population will consist of patients with spontaneous intracerebral hemorrhage confirmed by computed tomography (CT).

Patients will be assigned according to alternating weekly MSU or EMS deployment. During MSU weeks, patients undergo on-board CT, and those with intracerebral hemorrhage receive immediate prehospital blood pressure lowering. During EMS weeks, prehospital antihypertensive treatment is administered only in cases of severe hypertension (systolic blood pressure ≥220 mmHg), with blood pressure lowering initiated after in-hospital CT confirmation.

Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as assessed by blinded evaluation of the 90-day utility-weighted modified Rankin Scale (mRS).

It is hypothesized that the MSU pathway, compared to EMS, can enable earlier assessment and initiation of blood pressure lowering within 3 hours of symptom onset in patients with spontaneous intracerebral hemorrhage, thereby improving functional outcomes at 90 days.

Interventions

• Other Mobile Stroke Unit Management
  MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, enabling rapid diagnosis and prehospital management of acute stroke. Patients with suspected stroke undergo on-board CT imaging. Those diagnosed with intracerebral hemorrhage receive immediate prehospital blood pressure lowering. A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25
• Other Standard Management
  A regular ambulance. The standard management by EMS includes Electrocardiographic（ECG）monitoring, blood glucose management, airway, respiration, and blood pressure control, complication management, intravenous access establishment and other emergency measures. Prehospital antihypertensive treatment is administered only in cases of severe hypertension (systolic blood pressure ≥220 mmHg), with blood pressure lowering initiated after in-hospital CT confirmation.

Primary outcome measures

• Proportion of no or moderate disability [Time frame: 90 ± 7 days]

Secondary outcome measures (9)

• Hematoma volume [Time frame: 24±6 hours]
• Modified Rankin Scale (mRS) score [Time frame: 90 ± 7 days]
• Proportion of without severe disability [Time frame: 90±7 days]
• National Institutes of Health Stroke Scale (NIHSS) score [Time frame: 24 ± 6 hours and 7 ± 1 days]
• In-hospital mortality rate [Time frame: 7 ±1 days /discharge]
• All-cause mortality rate [Time frame: 90±7 days]
• Proportion of surgical interventions [Time frame: Within 7±1 days]
• Incidence of severe hypotension events [Time frame: 24±12 hours, 7±1 days]
• Health-related quality of life [Time frame: 90±7 days]

Eligibility criteria

Inclusion criteria

• History and physical/neurological examination consistent with acute stroke.
• Age ≥18 years;
• Time from symptom onset to enrollment <3 hours (onset defined as last known normal).
• Systolic blood pressure ≥150 mmHg and ≤220 mmHg;
• Pre-stroke modified Rankin Scale (mRS) score ≤2;
• Informed consent obtained from the subject or a legally authorized representative.

Exclusion criteria

• Glasgow Coma Scale (GCS) score ≤5.
• Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.
• Malignant disease or other serious primary illness with a life expectancy of <3 months.
• Current participation in another interventional randomized clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital — Beijing

Identifiers

NCT: NCT07665827 · [2026]093-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗